PER support from a team of IVD experts with inside industry experience.
With a team led by former notified body leadership who contributed to MEDDEV and MDCG guidance documents, RQM+ is uniquely positioned to help you create a strategy for presenting a comprehensive performance evaluation. We know what notified bodies are expecting, and will prepare your team and documentation accordingly.
With former notified body leaders on staff including Amie Smirthwaite, former Global Head of Clinical Compliance at BSI, and a team of seasoned experts dedicated to PERs, we have unique insights into what notified bodies will accept and creative strategies for how to respond to nonconformities.
Our global team has a unique combination of clinical and regulatory expertise, with a deep understanding of how IVDs work, how performance is measured, and what type of clinical evidence and analysis is required.
Led by our clinical team project managers, the RQM+ process begins with gaining a thorough understanding of your products, business objectives, and regulatory strategy. With a focus on demonstrating sufficient clinical data, we will help you implement innovative strategies for using existing data along with helping you create a PMPF plan to meet reviewer expectations.
The RQM+ validated process includes development of the PEP, literature search protocols/reports, and compilation of the PER which includes the state of the art analysis, scientific validity report, analytical performance report, and clinical performance report. We have multiple checkpoints with our clients to maintain alignment, as well as an internal review of the documents to provide the highest quality PER. The clinical regulatory strategy is applied throughout the process to ensure the result meets both yours and the notified body's expectations.
Using our performance evidence matrix and a comprehensive approach to gathering data across multiple departments, we will help you clearly identify gaps and weaknesses in data. We will then help you create a plan for the future, including rationales, justifications, and PMPF planning. Our integrated approach provides a complete picture for reviewers so that they can feel confident in approving the product for CE marking.
Seamless integration of PERs, PMS, and risk management is essential for more than just compliance—it will also save you money. Proper integration ensures data flows consistently across multiple procedures and departments. Why waste valuable resource time by having one department reproduce or reformat data to resolve inconsistencies in procedures and templates? RQM+ will ensure efficiency and effectiveness across the business, reducing opportunities for errors and nonconformities.
Learn more about our complete IVDR Clinical Evidence and PMS Solution
Performance evaluation reports and other documentation must be updated regularly to stay compliant. We can take on routine maintenance on a predetermined schedule so you don’t have to worry about missing deadlines or burdening your internal resources who need to be focused on new products.
Demonstration of sufficient clinical evidence is one of the most critical elements to achieving IVDR certification, and it extends beyond your PER to risk management, PMS, PMPF, and labeling. The RQM+ IVDR implementation team creates technical documentation files that convey a cohesive story of clinical evidence across functions and deliverables.
We have a team of IVD experts dedicated to creating IVDR technical documentation files. Our unrivaled collective knowledge is continuously growing and applied across all of our clients.
RQM+ is on the leading edge, supporting multiple clients with development of IVDR technical documentation files and PERs since 2020. As 2021 progresses and this number grows, we will also begin to get notified body feedback on early submissions and further refine our processes. The unrivaled collective knowledge at RQM+ will only continue to grow. The feedback our clients have received on CER submissions under MDR is representative of the quality of our work—one reviewer said we produced the best CERs they had ever seen. We get these results because every project lead is an expert with deep knowledge of the expectations of notified bodies and an understanding of what is sufficient to prove safety, performance, and state of the art. We apply the same level of rigor to our PERs.
The work is not done after certification is granted. Our team can update documents and create reports as new data arises—and periodically as required—so that you are always in compliance. Investing in ongoing maintenance also helps streamline updates to risk management and SSPs and the creation of PSURs.
Innovative Approach
We have mastered the science and art of creating clinical documents that tell a compelling story.
Clinical Expertise
Our team is filled with clinicians, engineers, and regulatory experts with experience in a large variety of IVD technologies.
Industry Experience
The RQM+ team has firsthand knowledge of the expectations of notified body reviewers.
Jon has a Ph.D. in mechanical engineering and more than 20 years of experience with medical devices. Jon is a prominent member of the RQM+ EU MDR and IVDR leadership teams, and also provides expert technical guidance for the company’s clinical practice.
“As a consultant, I’m involved in a wide range of projects which puts me in a position to monitor how regulatory bodies are enforcing the regulations. This enables me to help our clients navigate the gray areas and avoid common pitfalls so they can keep their devices on the market.”
Jaishankar “Jai” joined the RQM+ clinical team in February of 2021 after seven years at BSI where he held CE marking technical and clinical leadership roles. Jai is best at leveraging his unique blend of expertise combining cardiovascular product development- and CE marking-experience, towards supporting our clients with regulatory solutions and developing clinical strategies. His fresh-from-the-notified body perspective brings great insights and creative approaches to our clients.
“The paradigm shift in EU regulatory/clinical is real but it isn’t quite like mapping Mars either. Along with the talented, knowledgeable team at RQM+, I’m committed to helping retain legacy devices on the market and ensuring patients can benefit from innovative technologies.”
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